NCT01378351

Brief Summary

The purpose of this study is to characterize the accompanying symptoms, evaluation and management of patients with chronic vestibular dysfunction presenting with nausea and vomiting.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 22, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 26, 2013

Status Verified

August 1, 2013

Enrollment Period

1.2 years

First QC Date

June 21, 2011

Last Update Submit

August 22, 2013

Conditions

Dysfunction of Vestibular SystemNausea PersistentVomiting

Outcome Measures

Primary Outcomes (1)

  • Improvement of nausea and vomiting

    1 to 2 months

Secondary Outcomes (2)

  • Associated symptoms

    1 to 2 months

  • Alternate diagnoses

    1 to 2 months

Interventions

Questionnaire surveyOTHER

Mailed questionnaire investigating response to empiric treatment trials, further investigations by otolarygology and possible alternative diagnoses.

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatient gastroenterology clinic

You may qualify if:

  • Clinical symptoms of nausea and vomiting for at least 4 weeks
  • Abnormal modified Fukuda stepping test on examination (\>90 degree rotation from midline while marching in place for 60 seconds) or nystagmus or abnormal Rhomberg test

You may not qualify if:

  • Pregnancy
  • Unable to complete questionnaire survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Vomiting

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Lawrence Schiller, MD

    Baylor Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2011

First Posted

June 22, 2011

Study Start

June 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 26, 2013

Record last verified: 2013-08

Locations

US(1)